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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K854556
Device Name TRANSFER NEEDLE
Applicant
Soma Intl., Inc.
625 Montrose Ave.
S. Plainfield,  NJ  07080
Applicant Contact JAMES FITZGIBBONS
Correspondent
Soma Intl., Inc.
625 Montrose Ave.
S. Plainfield,  NJ  07080
Correspondent Contact JAMES FITZGIBBONS
Regulation Number880.5440
Classification Product Code
LHI  
Date Received11/14/1985
Decision Date 01/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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